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Profermin®: Prevention of Progression in Alcoholic Liver Disease by Modulating Dysbiotic Microbiota

NCT03863730 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-11-07

No results posted yet for this study

Summary

Investigators wishes to influence the gut microbiota in patients with alcoholic liver disease in a randomized controlled clinical trial. The investigators hypothesize that the alcohol-related dysbiosis seen in these patients can be changed and disease progression haltered by modulating microbiota with probiotics during 24 weeks.

Conditions

Interventions

DIETARY_SUPPLEMENT

Profermin Plus, FSMP, probiotics

Participants will have to supply their normal intake with Profermin Plus, FSMP, Prbiotics product twice every day for 24 weeks. The product Profermin Plus® has changed its name to ReFerm®. The content of the product is unchanged. The change occurred after the clinical part of the study was completed.

DIETARY_SUPPLEMENT

Fresubin, dietary supplement

Participants will have to supply their normal intake with the control product, Fresubin, dietary supplement twice every day for 24 weeks.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Odense Patient Data Explorative Network

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Nordisk Rebalance A/S

    collaborator INDUSTRY

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-07-15
Completion
2031-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863730 on ClinicalTrials.gov